Chloroxylenol is an antibiotic that treats infections caused by bacteria or fungus.

Hydrocortisone is a steroid. It reduces the actions of chemicals in the body that cause inflammation.

Pramoxine is a topical anesthetic. It works by interfering with pain signals sent from the nerves to the brain.

Cortane-B Aqueous (for the ear) is a combination medicine used to treat infections in the ear canal, and to relieve the symptoms of itching or swelling. Cortane-B Aqueous will not treat an inner ear infection (also called otitis media).

Medicinal use of this product to treat ear infections has not been approved by the FDA. Cortane-B Aqueous should not be used in place of medication prescribed for you by your doctor.

Cortane-B Aqueous may also be used for purposes not listed in this medication guide.

Medicinal use of this product to treat ear infections has not been approved by the FDA.

You should not use Cortane-B Aqueous if you have a hole in your ear drum (ruptured ear drum), or if you also have chickenpox or cowpox.

Follow all directions on your prescription label. Do not use Cortane-B Aqueous in larger or smaller amounts or for longer than recommended.

For best results, remove any ear wax or other debris before using this medicine. Ask your doctor about safe methods of ear wax removal.

To use the ear drops:

• Lie down or tilt your head with your ear facing upward. Open the ear canal by gently pulling your ear back, or pulling downward on the earlobe when giving this medicine to a child.

• Hold the dropper upside down over your ear and drop the correct number of drops into the ear.

• Stay lying down or with your head tilted for at least 5 minutes. You may use a small piece of cotton to plug the ear and keep the medicine from draining out.

• Another method of use is to insert a small piece of gauze into your ear and then drop in enough medicine to soak the gauze inside the ear canal.

• Leave the gauze in your ear for at least 24 hours, and keep it moist by adding a few drops of the medicine to the cotton every 4 hours.

• After removing the gauze, you may then place the drops directly into your ear 3 or 4 times daily. Use only the number of drops your doctor has prescribed.

• Follow your doctor's instructions about how long to keep using Cortane-B Aqueous ear drops.

Do not touch the dropper tip or place it directly in your ear. It may become contaminated. Wipe the tip with a clean tissue but do not wash with water or soap.

Call your doctor if your symptoms do not improve after 10 days of treatment.

Do not use Cortane-B Aqueous to treat any ear condition that has not been checked by your doctor.

Store at room temperature away from moisture and heat.

You should not use this medicine if you are allergic to chloroxylenol, hydrocortisone, or pramoxine or if you have:

• a hole in your ear drum (ruptured ear drum); or

• chickenpox or cowpox.

To make sure this medicine is safe for you, tell your doctor if you have:

• an inner ear infection;

• severe ear pain;

• hearing problems; or

• fever.

It is not known whether Cortane-B Aqueous will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

It is not known whether this medicine passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Do not give this medicine to a child without medical advice. Children can absorb larger amounts of this medicine through the ear canal and may be more likely to have side effects.

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

An overdose of Cortane-B Aqueous is not expected to be dangerous. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medication.

This medicine is for use only in the ears. Avoid getting the medicine in your eyes, mouth, and nose, or on your lips. Rinse with water if this medicine gets in or on these areas.

Do not use other ear medications unless your doctor tells you to.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Although the risk of serious side effects is low when this medicine is used in the ears, side effects can occur if hydrocortisone is absorbed into your bloodstream.

Steroid medicine absorbed through the skin inside your ears can cause steroid side effects throughout the body, such as: thinning skin, easy bruising, changes in the shape or location of body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

Stop using this medicine and call your doctor at once if you have severe burning or other irritation after using the ear drops.

Common side effects may include mild stinging or burning with the first use.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.